RWE Site Manager with SSU Experience

IQVIA; Warszawa; On-site; PLN 123,000 - 280,000; Full time

Job summary

IQVIA is seeking an RWE Site Manager with SSU experience to lead study start-up activities in Poland (home-based). You will focus on ethics committee submissions, contract negotiations with sites, and cross-functional collaboration to support site management and centralized monitoring.

The role requires proficiency in Polish and English (German or Romanian a plus) and a strong knowledge of regulatory requirements. You will manage regulatory packages, SIFs/CDAs, site contracts, and timelines.

Qualifications

• Experience in study start-up ethics committee submissions and contract negotiations.
• Proficiency in Polish and English; German or Romanian is a plus.
• Knowledge of regulatory landscape and experience in RWE or regular clinical trials.
• Central monitoring experience is nice to have with a willingness to learn and start this experience in the role.

Responsibilities

• Identify and select sites, collect SIFs and CDAs, and track documents.
• Conduct Site Selection Visits as needed.
• Prepare regulatory/ethics submissions and Essential Document Packages (EDPs).
• Conduct initiation, monitoring and close-out visits per scope.
• Serve as primary contact between site and sponsor; review CRF data and ensure documentation.
• Review and negotiate site contracts and budgets.
• Collaborate with cross-functional teams on site management and centralized monitoring.
• Review project plans and timelines.

Skills

Study start-up submissions

Contract negotiations

Polish language

English language

Regulatory landscape knowledge

RWE/clinical trials experience

Central monitoring experience

Job description

Job Title: RWE Site Manager with SSU Experience
Location: Poland; Home-Based

Job Overview:
As an RWE Site Manager you will play a pivotal role in the study start-up process focusing on ethics committee submissions and contract negotiations with sites. You will collaborate with cross-functional teams to support site management and centralized monitoring. Your expertise in the regulatory landscape coupled with your experience in RWE or regular clinical trials will be crucial in ensuring compliance and operational efficiency. Proficiency in Polish and English is required with German or Romanian being a significant advantage.

Responsibilities:

• Perform site identification and selection activities including collecting Site Information Forms (SIF) and Confidentiality Disclosure Agreements (CDA) and tracking and filing these documents.
• Conduct Site Selection Visits (SSVs) as needed.
• Manage study start-up activities including preparing ICF country adaptation, regulatory/ethics submission packages and obtaining necessary approvals; including preparation and management of Essential Document Packages (EDPs),ensuring sites meet all requirements for initiation and activation.
• Performs as needed, initiation, monitoring and close out visits remotely and in accordance with contracted scope of work.
• Serves as primary contact between the business and the investigator site including remote review of Case report Form (CRF) data, timely transmission of clinical data from assigned studies, works with sites on query resolution and final data review; and ensures proper documentation of site management communications.
• Collect review and file site regulatory documents ensuring completeness and accuracy.
• Prepare review and negotiate site contracts and budgets with investigator sites.
• Collaborate with cross-functional teams to support site management and centralized monitoring.
• Review and agree on project planning and timelines.

Qualifications:

• Experience in study start-up ethics committee submissions and contract negotiations.
• Proficiency in Polish and English; German or Romanian is a plus.
• Knowledge of the regulatory landscape and experience in RWE or regular clinical trials.
• Central monitoring experience is nice to have with a willingness to learn and start this experience in the role.

Disclaimer:
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties responsibilities and qualifications required of employees assigned to this job. At IQVIA we believe that diversity inclusion and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone everywhere. When our talented employees bring their authentic selves and their diverse experiences to work they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is zł122,900.00 - zł280,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.